Date: 2014-09-09
Type of information: Presentation of results at a congress
phase: 2a
Announcement: presentation of results at the 2014 ACR / ARHP Annual Meeting, to be held in Boston, Massachusetts, USA on 14 - 19 November 2014
Company: SuppreMol (Germany)
Product: SM101
Action
mechanism: SM101 is a recombinant, soluble, non-glycosylated version of the human Fcgamma receptor Fcgamma RIIb. It binds to autoantibody/autoantigen complexes and blocks the triggering of Fcgamma receptors on the surface of immune cells. As a result, the immune response is downregulated and the activation of the inflammation cascade typically seen in autoimmune diseases is prevented. The product has a short half-life and the patient's immune competence is restored once the product is washed out of the circulation. Moreover, non-target B-cells (i.e., B-cells participating in regular immune reactions) are unaffected, so that possible side-effects such as increased susceptibility to infections are not expected.
SM101 has been validated in relevant animal models and has shown strong efficacy in terms of decrease in inflammation and autoimmune reaction.
Disease: systemic lupus erythematosus
Therapeutic area: Autoimmune diseases
Country: Australia, Belgium, the Czech Republic, France, Germany, Italy, Poland, Spain, UK
Trial
details: The multi-centric, randomized, double-blind, placebo-controlled, parallel group Phase IIa study has enrolled 51 systemic lupus erythematosus patients with or without a history of Lupus Nephritis and a SELENA-SLEDAI score of more than 6 and active serological status. Over four weeks, two groups of twenty patients each will intravenously receive 6 or 12 mg/kg/week of SM101, while 10 patients will receive placebo. 30 clinical sites in Australia, Belgium, the Czech Republic, France, Germany, Italy, Poland, Spain, and the UK have participated. The primary end point of this feasibility study is the safety of the drug, as measured by the frequency of side effects on the basis of CTCAE criteria (Common Terminology Criteria for Adverse Events). Further safety end points include vital parameters, body temperature and weight, electrocardiogram, certain laboratory parameters, and the occurrence of anti-drug antibodies (ADA). The efficacy of the drug will be documented with a status assessment of the disease, possible renal complications (lupus nephritis) and the detection of proteinuria, urine sediment, and a number of biomarkers as compared to placebo. The use of emergency medications will also be a factor of the efficacy assessment of SM101 vs. placebo. The study results are expected for the year 2013.
Latest
news: * On September 9, 2014, SuppreMol, a biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases, announced that an abstract detailing phase IIa clinical data of SM101 in SLE patients has been accepted for presentation at the 2014 ACR / ARHP Annual Meeting, to be held in Boston, Massachusetts, USA on 14 - 19 November 2014. The abstract "SM101, a Novel Recombinant, Soluble, Human FcyIIB Receptor, in the Treatment of Systemic Lupus Erythematosus: Results of a Double-Blind, Placebo-Controlled Multicenter Study" will be presented in the session "Systemic Lupus Erythematosus - Clinical Aspects and Treatment: Novel Therapies for Systemic Lupus Erythematosus" on Tuesday, November 18 at 2:30 PM EST (Presentation Number 2787). The phase IIa clinical trial enrolled 51 SLE patients for six months. Patients received 6 mg/kg or 12 mg/kg SM101 or placebo and randomized to a ratio of 2:2:1. The clinically relevant endpoints were SLEDAI, BILAG, PGA and Overall Response, equivalent to the Responder Index. SM101 showed a clear numerical dose response in all four key endpoints at six months. SM101 confirmed its excellent safety profile in this clinical trial. * On July 11, 2011, SuppreMol announced the initiation of a Phase IIa clinical trial with its lead product SM101 in systemic lupus erythematosus. The primary endpoint of the proof-of-concept trial is safety based on the incidence of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE). Further safety endpoints comprise, among others, vital signs, body temperature, body weight, electrocardiogram, safety laboratory assessments, and the occurrence of anti-drug antibodies (ADAs). Efficacy is determined by overall and renal disease score assessments, proteinuria, urine sediment, a number of biochemical, biological and molecular markers, and use of rescue medication. Results of the trial are expected for 2013. SM101 already has been shown to have an excellent safety and tolerability profile as well as favorable pharmacokinetics in a Phase Ia trial in 48 healthy volunteers completed in 2009. Subsequently, a Phase Ib/IIa multi-center clinical trial for the treatment of Primary Immune Thrombocytopenia (ITP) was started in early 2010.
